JP2018504208A - Auxiliary device for attaching to a pen-type syringe and determining a set dose using an optical incremental encoder - Google Patents

Abstract

The data collection device includes at least two optical sensors configured to detect a scale of the drug dose indicator of the drug delivery device within its respective detection area, and during programming of the drug dosage into the drug delivery device And a processing device configured to determine a current medication dosage programmed into the medication delivery device based on a count of graduations passing through the detection area of the optical sensor. The direction of the scale stroke can be identified to determine whether the programmed dosage is increasing or decreasing. The device can be arranged to identify the reference dose using the camera image of the drug dose indicator, and thus can determine the starting point for the graduation count. The drug delivery device can be an injection pen.

Description

  The present invention relates to data and methods for collecting drug dosage information from drug delivery devices.

  There are various illnesses that require regular treatment by injection of drugs. Such injections can be performed by using an injection device that is applied by a healthcare professional or the patient himself. As an example, type 1 and type 2 diabetes can be treated by the patient himself, for example by injection of one or several insulin doses per day. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can be used. A reusable pen allows an empty drug cartridge to be replaced with a new one. Both pens may come with a set of one-way needles that are replaced before each use. In that case, manually select the insulin dose to be injected, for example by turning the dose knob on the insulin pen and observing the actual dose from the insulin pen dose window or display Can do. The dose is then injected by inserting a needle into the appropriate part of the skin and pressing the injection button on the insulin pen.

  For example, to prevent insulin pen mishandling, or to allow monitoring of insulin injections to keep track of already applied doses, for example, one of the types of insulin injected, the dose and the timing of the injection It is desirable to assess information relating to the condition and / or use of the injection device, such as or more, in a reliable and accurate manner.

  U.S. Patent No. 6,099,077 discloses an apparatus configured to releasably attach to a medical device or to releasably receive at least a portion of a medical device such as an injection pen. The apparatus uses one or more opticals to determine information related to the condition or use of the medical device, such as the dosage to be dispensed by the device, which the user programs to the device using optical character recognition. Includes type sensors.

WO2011 / 117212A1

  According to one aspect, there is provided a data collection device configured to be attached to a drug delivery device or to releasably receive at least a portion of the drug delivery device, each data collection device being a respective detection. At least two optical sensors arranged to detect light from the area and a processing device, the optical sensor for detecting a scale of the drug dose indicator of the drug delivery device within its respective detection area And the processing device is configured to program a current medication programmed into the medication delivery device based on a count of graduations passing through a detection area of an optical sensor during programming of the medication dosage into the medication delivery device Configured to determine dosage.

  Because the dosage is automatically determined during the programming, the user of the drug delivery device does not need to perform additional actions to record the dosage. For example, the user need not acquire an image of the drug dose indicator, particularly to record the drug dosage.

  In addition, the processing required to determine the dosage using a “light barrier” type technique can eliminate the need for pre-processing, particularly to correct exposure levels and other parameters, so Compared with a device that uses a simple optical character recognition algorithm, the complexity can be reduced.

  Also, when a camera is provided for a data collection device, the technical requirements for resolution and dynamic range for that camera are compared to the camera in a device that relies entirely on optical character recognition to determine the programmed dose. It is possible to reduce annoyance. For example, the camera captures at least a portion of the drug dosage indicator and provides to determine an initial drug dosage displayed in the window corresponding to an expected base amount such as zero units As a result, the absolute value of the count can be surely known. Such a determination can be based on the identification of at least one character or marking shown in the image. Because the expected reference amount exists, the processor compares the captured image with a template corresponding to the predicted image of the dosage window when the expected reference amount is displayed, and calibrates the count; and It can be configured to ensure that the scale counts start from a suitable initial value. If the captured image does not match the template, an audible and / or visual warning can be generated.

  If a camera is provided, the data collection device is indicated by the drug dosage indicator because it may obscure the user's view of the drug dosage window when the data collection device is attached to the drug delivery device A display can be included to indicate the dosage. In such an embodiment, the displayed dosage can be calculated based on the expected reference amount plus the current count of detected scales. By determining the dosage to be displayed to the user in this way, the need for a complete optical character recognition process can be avoided.

  The direction in which the scale is moving can be determined using the order in which the sensor detects the scale passing through its respective detection area. The direction of the stroke can then be used to determine whether the programmed dosage is increasing or decreasing.

  The data collection device can be configured to determine that the programmed dosage has not changed if the output of the optical sensor does not change over time.

  The data collection device can be configured to be releasably attached to the drug delivery device to allow it to be reused with other drug delivery devices. In certain instances, the drug delivery device is a disposable injection pen and the data collection device can be reused with another injection pen or exchanged between injection pens as needed.

  This aspect also provides a drug delivery system that includes any of the data collection devices discussed previously with a drug delivery device.

  The drug delivery device can be an injection pen. In particular, the drug delivery device can be a disposable injection pen. However, in other embodiments, the data collection device can be configured for use with other drug delivery devices.

  According to another aspect, a method for collecting dosage information from a drug delivery device uses two optical sensors to present the drug dosage of the drug delivery device that is present in the detection area of each of the two optical sensors. Detecting the scale of the quantity indicator, counting the scale passing through the detection area during programming of the drug dosage into the drug delivery device, and using the processing device, the drug delivery based on the result of the count Determining a current drug dosage programmed into the device.

  The method also includes using the processing device to determine whether the current drug dosage is increasing or decreasing based on the order in which the optical sensor detects the scale within the respective detection area.

  Alternatively or additionally, the method can include determining an initial drug dosage displayed by the drug dosage indicator, and the processing device can determine a current drug based on the initial drug dosage and the count. Configured to calculate dosage. In one example, determining the initial drug dosage includes capturing an image of at least a portion of the drug dosage indicator using a camera and identifying at least one letter or mark in the image.

  The method determines whether the count has changed within a predetermined time, and if it is determined that the count has not changed during the predetermined time, the final programmed in the drug delivery device Outputting an indication of the determined drug dosage, wherein the final determined drug dosage corresponds to a current drug dosage.

  In some embodiments, the drug delivery device is an injection pen. For example, the drug delivery device can be a disposable injection pen for insulin delivery. However, this method can be used to collect dosage information from an injection pen for delivering other medications, or from other types of drug delivery devices.

  Next, exemplary embodiments of the present invention will be described with reference to the accompanying drawings.

1 is a perspective view of an exemplary drug delivery device from which dosage information can be collected. FIG. FIG. 3 is a detailed view of a portion of a drug delivery device including a dosage window. FIG. 2 is a perspective view of a data collection device according to an embodiment of the present invention attached to the drug delivery device shown in FIG. FIG. 4 is a block diagram illustrating components of the data collection device of FIG. 3. It is a figure which shows an example of the optical sensor which can be used for the data collection device of FIG. It is a figure which shows arrangement | positioning of two optical sensors in the data collection device of FIG. FIG. 2 shows the intensity of light received by an optical sensor and the output signal from the optical sensor in the device of FIG. 1 when a dosage is programmed into the drug delivery device. FIG. 2 shows the intensity of light received by an optical sensor and the output signal from the optical sensor in the device of FIG. 1 when a dosage is programmed into the drug delivery device. 3 is a flow diagram of a method according to an embodiment of the invention.

  In the following, embodiments of the invention will be described in the context of data collection from an insulin injection device, such as Sanofi's SoloSTAR® pen. However, the present invention is not limited to such applications, as previously mentioned herein, data with or from injection devices that release other drugs, or other types of drug delivery devices. In applications other than collection, it can be used appropriately as well.

  FIG. 1 is an exploded view of a drug delivery device. In this example, the drug delivery device is an injection device 1 such as Sanofi's SoloSTAR® insulin injection pen.

  The injection device 1 of FIG. 1 is a pre-filled disposable injection pen that includes an insulin container 14 with a housing 10 to which a needle 15 can be attached. The needle is protected by an inner needle cap 16 and an outer needle cap 17, which can be covered by a cap 18. The insulin dose to be released from the injection device 1 can be selected by turning the dosage knob 12, and then the selected dose is passed via the dosage window 13, for example the so-called International Unit (IU). Where 1 IU is the bioequivalent amount of about 45.5 micrograms of pure crystalline insulin (1/22 mg). An example of a selected dose displayed in the dosage window 13 is, for example, 30 IU as shown in FIG. It should be noted that the selected dose can be appropriately displayed in different ways as well.

  The dosage window 13 can be in the form of an aperture in the housing 10 so that the user sees a limited portion of the numeric sleeve 71 configured to move as the dosage knob 12 is turned. It becomes possible.

  Turning the dosage knob 12 creates a mechanical click and provides audible feedback to the user. The number sleeve 71 mechanically interacts with the piston in the insulin container 14. When the needle 15 is inserted into the patient's skin and then the injection button 11 is pressed, the insulin dose displayed in the dosage window 13 is released from the injection device 1. After the injection button 11 is pressed, a high percentage of the dose is actually injected into the patient's body when the needle 15 of the injection device 1 stays in the skin part for a certain period of time. The release of the insulin dose also produces a mechanical click sound that is different from the sound produced when using the dosage knob 12.

  The injection device 1 can be used for multiple injection processes until the insulin container 14 is empty or until the expiration date of the injection device 1 is reached (eg, 28 days after the first use).

  Furthermore, before using the injection device 1 for the first time, for example, by selecting 2 units of insulin and pressing the injection button 11 while holding the injection device 1 with the needle 15 facing upward, the so-called “prime shot” May be necessary to remove air from the insulin container 14 and the needle 15.

  For ease of explanation, it will be assumed in the following that, by way of example, it is assumed that the released dose substantially matches the injected dose, so that, for example, when planning the next scheduled dose, this dose is Equal to the dose that the injection device must release. However, of course, the difference (eg loss) between the released dose and the injected dose can also be taken into account.

  FIG. 2 is a detailed view of the end of the injection device 1 showing a positioning rib 70 located between the viewing window 13 and the dosage knob 12.

  FIG. 3 illustrates a data collection device 2 according to one embodiment of the present invention that can be used to collect dosage information once attached to the drug delivery device 1.

  In this particular embodiment, the data collection device 2 includes two housing parts 2a, 2b connected by a hinge 2c. The data collection device 2 places a part of the drug delivery device 1 in one recess of the housing part 2a, 2b and closes the housing part 2a, 2b around the housing 10 of the drug delivery device 1 by It is releasably attached to the drug device 1. The positioning ribs 70 interact with cooperating components 72 on the data collection device such that the data collection device 2 is positioned at an appropriate location on the drug delivery device 1 and collects dosage information from the dosage window 13. Works.

  FIG. 4 is a block diagram of the data collection device 2. In this particular example, the data collection device comprises two or more optical sensors 25 with associated D flip-flops 29, a camera 24 and a controller 26. The controller 26 is a processing device that includes one or more processors, such as a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate array (FPGA). The data collection device 20 also includes memory units 240, 241, including a program memory 240 and a main memory 241 that can store software for execution by the controller 26. The data collection device 20 also includes a wireless unit 28 that allows two-way communication through the network, such as a personal area network or a Bluetooth network, or a local radio access network (WLAN). A display 21 and optionally an acoustic signal generator 23 are provided to provide visual output and, if necessary, sound output. The data collection device 20 is powered by a battery 27 and a power button 22 is arranged to switch the device on and off.

  For ease of understanding, each component of the data collection device 20 is shown as one block in FIG. In the embodiment shown in FIG. 3, the components are distributed between the housing portions 2a, 2b of the data collection device 20. For example, a display 21, an acoustic signal generator 23, if provided, and a battery 27 are provided to one of the housing parts 2a, a controller 26, an optical sensor 25, a D-type flip-flop 29, a camera 24, a power button 22 And a radio unit 28 can be provided in the other housing part 2b. However, the distribution of the components of the data collection device 20 is not limited to that particular configuration. In other embodiments, the housing portions 2a, 2b can include combinations of components that differ from the combinations described herein.

  FIG. 5 is a circuit diagram of one optical sensor 25a in the data collection device 20 as an example. The optical sensor 25a includes a light source 30a such as a light emitting diode (LED), and a photodetector 31a. In this particular example, light source 30a emits infrared (IR) radiation having a wavelength of 940 nm.

  When the data collection device 20 is attached to the drug delivery device 1, the optical sensor 25a is positioned over the dosage window 13, so that the light emitted from the light source 30 is detected by the detection area of the optical sensor 25a. It enters the scale 50 on the number sleeve 71 in 32a. Preferably, in order to facilitate the detection of the scale by the optical sensor 25a, the housing parts 2a, 2b are configured such that the detection region 32 is not exposed to ambient light.

  The light reflected from the number sleeve 71 is received by the photodetector 31a. The intensity of light received by the photodetector 31a at a specific moment indicates whether the scale 50 is present in the detection region 32a. In this particular example, the detection area 32a is configured to have a narrow width, and the intensity of the received light increases as the scale 50 is moved through the detection area 32a, and then the next scale is in the detection area 32a. Until entering, the scale 50 becomes smaller as it leaves the detection area 32a. In other embodiments, the intensity of light received by the sensor 25a may be reduced as the scale 50 enters the detection region 32a, depending on the reflectance of the scale on the number sleeve 71 with respect to the background.

  In this particular embodiment, two optical sensors 25a, 25b are provided as shown in FIG. 6, each of which is arranged to monitor the light sources 30a, 30b and the respective detection areas 32a, 32b. Devices 31a and 31b.

  In FIG. 6, the detection areas 32a and 32b are shown apart for easy viewing. However, in this particular embodiment, the detection areas 32a, 32b are moved in a first direction through the dosage window and the scale 50 moves to enter the detection area 32b for the first one 25b of the optical sensor. And arranged so as to be detected by the sensor. As the dosage continues to increase, the scale 50 moves and enters the detection area 32a of the other optical sensor 25a. The example shown in FIG. 6 also includes a reference detection marking 51 on the numeric sleeve 71 that can be used to determine whether a reference dosage is shown in the dosage window 13.

  FIG. 7A shows an example of the intensity of light received by the optical sensors 25a and 25b in the arrangement in which the detection regions 32a and 32b are located close as described above. When the user turns the knob 12 to increase the dosage, the scale 50 enters the detection area 32b, the output of the optical sensor 25b indicated by the solid line increases, and remains high until the scale 50a moves out of the detection area 32b. . The intensity of the received light remains low until the next scale 50b enters the detection area 32b.

  Before the scale 50a exits the detection area 32b, its leading edge moves to enter the detection area 32a, and the optical sensor 25a receives until the scale 50a exits the detection area 32a as indicated by the dotted line. The intensity of light increases.

  Parts (b) and (c) of FIG. 7 show signals output by the optical sensors 25a and 25b, respectively. These signals have a high level or a low level depending on whether the intensity of light received by the sensors 25a, 25b exceeds a predetermined threshold. A solid line indicates an output from the sensor 25b, and a dotted line indicates an output from the sensor 25a. In this particular embodiment, the count is incremented when the trailing edge of each scale 50a, 50b exits the detection area 32a. The timing when the count is increased is shown as t1 and t2.

  FIG. 8 shows the intensity of light received and the output of the optical sensor in an example where the user completes the dosage programming at time t3. In this particular example, the scale is in the detection area 32b and has just started entering the detection area 32a. The controller 26 is configured to detect when a predetermined time tx has elapsed without changing the output signal or the count itself. In this example, the time tx is set to 8 seconds.

  At time t4, time tx has elapsed and the controller 26 determines that the final determined drug dosage is the initial dosage adjusted by the count result.

  In addition to the controller 26 using the count itself, signals from the optical sensors 25 a, 25 b are provided as inputs to the D-type flip-flop 29. The output from the D-type flip-flop 29 based on the order in which the rising edges of the signals from the optical sensors 25a, 25b are detected will be high or low, and therefore depends on the direction in which the scale is moved. To do. Therefore, the controller 26 can determine the direction of the stroke and whether the drug dosage is increasing or decreasing based on the output signal from the D-type flip-flop 29.

  Next, a method for collecting dosage information will be described with reference to FIG.

  Beginning at s9.0, an image of at least a portion of the dosage window 13 is captured using the camera 24 (step s9.1).

  The image is then processed by the controller 26 to determine if the dosage currently displayed in the dosage window is an expected initial value (step s9.2). For example, some injection pens automatically reduce the number 19 displayed in the dosage window 13 to zero when an injection is administered, so the user programs the dosage for the next injection. It is expected that the initial value previously shown in the dosage window 13 will be zero or some other expected reference dosage, or should display a letter representing the same. If this check is not performed, the actual dosage programmed into the injection pen 1 cannot be reliably determined.

  As previously mentioned, in this particular example, a reference detection marking 51 is included on the numeric sleeve 71. The reference detection marking 51 can be a pattern or other mark such as a two-dimensional code that can be detected by a camera if provided. The reference detection marking 51 can be visible at an optical wavelength and / or other wavelengths. In this particular example, the reference detection marking 51 is printed on the number sleeve 71 using ink that can be recognized at infrared (IR) wavelengths, and the camera 24 detects the reference detection marking 51 in order to detect the reference detection marking 51. Configured to be sensitive to IR radiation reflected from 71. Since the position of the camera 24 relative to the dosage window 13 is determined by the positioning rib 70, when the displayed dosage matches the expected reference dosage, the reference detection marking 51 is at a specific position in the image captured by the camera 24. Expected to appear. In the example shown in FIG. 6, the expected reference dosage is zero IU.

  Alternatively or additionally, the number printed on the number sleeve 71 can be used to determine whether the drug dosage initially shown in the dosage window 13 corresponds to the expected reference dosage. In one example, one or more characters that can be recognized are selected, for example, one or more characters having a maximum height. Pattern matching is performed based on a template stored in one of the memories 240, 241 of the data collection device 20 that corresponds to the expected reference dosage. Since the position of the camera 24 relative to the dosage window 13 is determined by the positioning rib 70, the selected character should give a reasonable to the template if it corresponds to the expected reference dosage. The comparison can be performed, for example, pixel by pixel, or using a feature recognition process or a vector comparison process.

  In other embodiments, a more sophisticated optical character recognition process can be used to identify selected characters.

  The user can use the reference detection marking 51 and / or the numeric recognition on the numeric sleeve 71 to verify the drug dosage initially displayed in the dosage window 13 to calibrate the measurement to be made. A reliable determination of the actual value of the programmed dosage can be made without the need to carry out any additional steps.

  If it is found that the dosage displayed in the dosage window 13 does not match the expected reference dosage (step s9.2), a warning message is generated and displayed on the display 21 and / or an acoustic signal An audible alarm is generated using the generator 23 (step s9.3).

  If the displayed dosage matches the expected reference dosage (step s9.2), the data collection device 20 starts monitoring the dosage window 13 using the optical sensors 25a, 25b (step s9. 4) The scale 50 moving through the detection areas 32a and 32b is detected.

  If a change is detected in the output of the optical sensors 25a, 25b within the predetermined time tx (step s9.5), the output from the D-type flip-flop 29, as previously discussed herein. Is used to determine whether the dosage programmed into the injection pen 1 is increasing or decreasing (step s9.6).

  The count is then adjusted (step s9.7) and the current dosage is determined (step s9.8). The output of the display 21 is updated to show the newly determined current dosage (step s9.9).

  Steps s9.4 to s9.9 are repeated, and therefore the current dosage displayed on the count and display 21 continues to be updated based on the detection of the scale by the optical sensors 25a, 25b.

  When the user completes the programming of the dosage into the injection pen 1, the optical sensors 25a, 25b will no longer detect changes. If time tx has elapsed since the previous change in the output of the optical sensor (step s9.5), or if the count did not change during time tx in an alternative embodiment, the current dosage is It is regarded as the final drug dosage, ie the dosage administered by the user (step s9.10). In some embodiments, a message can be output using display 21 and / or acoustic signal generator 23 to prompt the user to confirm the final drug dosage.

  The final drug dosage is then stored in the program memory 240 (step s9.11) and optionally transmitted to other devices such as a computer, tablet device or smartphone using the wireless unit 28 (step s9. 12).

  Next, the data collection process ends (step s9.13).

  Although the above embodiments have been described with respect to data collection from insulin injection pens, embodiments of the present invention can also be used for other purposes, such as injection of other drugs or monitoring of other medical processes. Please note that.

Claims (15)

A data collection device configured to be attached to a drug delivery device or to releasably receive at least a portion of the drug delivery device:
At least two optical sensors, each arranged to detect light from a respective detection area;
A processing device;
Where, where
The optical sensor is configured to detect a scale of the drug dose indicator of the drug delivery device within its respective detection region;
A processor determines a current drug dosage programmed into the drug delivery device based on a count of graduations passing through a detection area of an optical sensor during programming of the drug dosage into the drug delivery device. Configured to
Said data collection device.   The data of claim 1, wherein the optical sensor is configured to determine whether the current drug dosage is increasing or decreasing based on the order in which the scale is detected within each respective detection region. Collection device.   Claims configured to determine an initial drug dosage displayed by a drug dosage indicator, wherein the processing device is configured to calculate a current drug dosage based on the initial drug dosage and the count. Item 3. The data collection device according to Item 1 or 2.   Including a camera configured to capture an image of at least a portion of the drug dosage indicator, wherein the processing device determines the initial drug dosage by identifying at least one letter or mark shown in the image The data collection device according to claim 3, wherein the data collection device is configured as follows.   The data collection device of claim 4, wherein the processing unit is configured to identify the at least one character based on a stored template corresponding to an expected initial drug dosage.   6. A data collection device according to any preceding claim, configured to output an indication of a current drug dosage in response to a change in count.   The processing device determines whether the count has changed within a predetermined time, and if it is determined that the count has not changed during the predetermined time, a final decision programmed into the drug delivery device 7. Data collection according to any one of the preceding claims, configured to output an indication of a determined drug dosage, wherein the final determined drug dosage corresponds to a current drug dosage device. A drug delivery system comprising:
A data collection device according to any one of claims 1 to 7;
The drug delivery system comprising the drug delivery device.   The drug delivery system of claim 8, wherein the drug delivery device is an injection pen. A method for collecting dosage information from a medical delivery device comprising:
Using two optical sensors to detect a scale of a drug dosage indicator of the drug delivery device that is present in the detection area of each of the two optical sensors;
Counting the graduation passing through the detection area during programming of the drug dosage into the drug delivery device; and using a processing device, based on the result of the count, the current drug programmed into the drug delivery device Said method comprising determining a dosage.   11. Using a processing device, including determining whether the current drug dosage is increasing or decreasing based on the order in which the optical sensor detects a scale within the respective detection area. The method described in 1.   Determining the initial drug dosage displayed by the drug dosage indicator, wherein the processing device is configured to calculate a current drug dosage based on the initial drug dosage and the count. The method according to 10 or 11.   The determination of the initial drug dosage comprises capturing an image of at least a portion of a drug dosage indicator using a camera and identifying at least one letter or mark shown in the image. the method of.   Determining whether the count has changed within a predetermined time, and if it is determined that the count has not changed during the predetermined time, the final determined programmed into the drug delivery device 14. A method according to any one of claims 10 to 13, comprising outputting an indication of a drug dosage, wherein the final determined drug dosage corresponds to a current drug dosage.   15. A method according to any one of claims 10 to 14, wherein the drug delivery device is an injection pen.

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